Summary of Part D Revisions

11/07/06

High-Level Summary of All Part D Application Revisions from 2007 Solicitation for the 2008 Solicitation

Clarification	Purpose of the Clarification			Application
				PDP		MA-PD	Cost
GENERAL INFORMATION
Dates modified throughout documents to reflect 2007 contract year.		The original applications gave a date for the 2007 contract year and the implementation of the benefit. This change updates for the forthcoming contract year.	Throughout document		Throughout document			Throughout document
Changed website references and attestations requiring applicants to comply with additional Part D guidance.		Changed website references to general CMS website to avoid any wrong or outdated links.	Throughout document		Throughout document			Throughout document
INSTRUCTIONS
Delete Notice of Intent to Apply section.	This section has been made into a separate document to facilitate the automation of the application process.			2.3		2.3	2.3
Clarify the overall instructions to complete the 2008 solicitations.	Clarifies: That the majority of the solicitation will be completed through HPMS and identifies throughout application which parts are to be completed in HPMS and which parts are to be submitted to CMS; That the applicant agrees to abide by the forthcoming call letter; The submission process for solicitation of attachments. Each pending contract number must be submitted through HPMS separately, but the supporting documentation may be combined.			2.4 HPMS Instructions are throughout document		2.4 HPMS Instructions are throughout document	2.4 HPMS Instructions are throughout document
Adds instructions for the pharmacy access requirements.	Incorporates the Pharmacy Access Submission from previous years into the overall solicitation document.			2.8 3.4		2.8 3.4	2.8 3.3
APPLICANT EXPERIENCE, CONTRACTS, LICENSURE AND FINANCIAL STABILITY
Management and Operations
Deletes non-governmental from the MA-PD and Cost applications.	MA-PD and Cost applicants may be governmental entities.			N/A		3.1.2A2	3.1.2A2
Added 2 subcontractor functions for who performs pharmacy technical assistance and who maintains the P&T committee	Identifies entity that provides two more detailed Part D functions identical to those required in the 2007 Reporting Requirements.			3.1.2E		3.1.2E	3.1.2E
Licensure and Solvency
Clarifies the licensure and solvency attestation related to waivers.	Deletes language that an applicant will complete the request for waiver of state licensure requirements thereby clarifying CMS’ expectation that this request is made to the State prior to submitting application to CMS.			3.1.4A4		N/A	N/A
HPMS Part D Contacts
Adds a new section for HPMS contacts.	Instructs the applicant to complete the part of HPMS that provides contact information for key Part D contacts within an organization.			3.1.6		3.1.5	3.1.5
BENEFIT DESIGN
Quality Assurance and Patient Safety
Delete attestation addressing drug and food allergy information and patient counseling.	These are not regulatory requirements.			3.2.3A4 and A6		3.2.3A4 and A6	3.2.3A4 and A6
Bids
Adds a new attestation related to direct and indirect remuneration for the bids.	Incorporates guidance from the 2007 call letter.			3.2.6A3		3.2.6A2	3.2.6A2
PHARMACY ACCESS
Added new attestation related to PBM subcontractor changes.	Adds attestation to instruct applicant to notify CMS when PBM is changed.			3.4A9		3.4B9	3.3A9
Added new attestation to notify CMS of major pharmacy network changes.	Adds attestation to instruct applicant to notify CMS when there has been a substantive change in the organization’s pharmacy network.			3.4A10		3.4B9	3.4A10
Retail Pharmacy
Added new attestations to identify those Applicants seeking to obtain any of the allowable pharmacy access waivers.	These attestations allow CMS to identify those applicants seeking the pharmacy access waivers within HPMS and provide the applicants with instructions for completing the required tables within the solicitation related to those waivers. Previously these were separate parts of the Pharmacy Access Submission document that have been consolidated in an easier fashion for the applicant.			N/A		3.4.1A4 3.4.1A5	3.3.1A4 3.3.1A5
Added a new instruction to submit discussion for areas that fail to meet access standards.	Adds section that gives detailed instructions to submit a supporting discussion of why the access standard could not be met in a specific part of the service area.			3.4.1D		3.4.1H	3.3.1H
Home Infusion Pharmacy
Adds new attestations for home infusion pharmacy access.	Reflects home infusion guidance that was issued by CMS in the 2007 call letter and HPMS guidance.			3.4.4A3-5		3.4.4A3-5	3.3.4A3-5
Long-Term Care Pharmacy
Added new attestation related to LTC contracting and providing a uniform benefit.	Reflects LTC guidance that was issued by CMS during the 2006 calendar year.			3.4.5A7		3.4.5A7	3.3.5A7
ITU Pharmacy
Adds new attestation for submission of proof of offerings of contracts to ITU pharmacies.	Allows CMS to accept documentation from applicant demonstrating the offering of contracts to all ITU pharmacies in the applicant’s service area.			3.4.6A3		3.4.6A3	3.3.6A3
Specialty Pharmacy
Adds new section of attestations for specialty pharmacies.	Reflects guidance from the 2007 call letter related to access to specialty pharmacies.			3.4.7		3.4.7	3.3.7
ENROLLMENT AND ELIGIBILITY
Added new attestations related to processing enrollments, reviewing creditable coverage, and performance metrics related to enrollment and eligibility.		Reflects guidance from the 2007 call letter and HPMS guidance related to enrollment.	3.5A19-23		3.5A1-5			3.4A15-20
COMPLAINTS TRACKING MODULE
Added new section related to applicant responsibilities with tracking complaints.		Adds attestations to reflect guidance released during 2006 related to tracking and resolving complaints via CMS’ complaint tracking module.	3.6		3.6			3.5
MEDICARE PRESCRIPTION DRUG PLAN FINDER
Added new section related to applicant responsibilities to provide accurate information to the Medicare Prescription Drug Plan Finder.		Adds attestations to reflect guidance released during 2006 related to the Medicare Prescription Drug Plan Finder.	3.7		3.7			3.6
EXCEPTIONS, APPEALS AND GRIEVANCES
Incorporates language into an existing attestation related to children and the exception and appeals process.	Reflects guidance issued by CMS during 2006 related to children that are on Medicare.			3.9A3		3.9A3	3.8A3
Deletes the requirement that applicants submit a complete description of its policies and procedures for exceptions and appeals and coverage determinations.	The attestations specify the requirements applicants are expected to follow and the submission of the policies and procedures has proven burdensome. Attestations include having the policies and procedures available upon request.			3.9B		3.9B	3.8B
COORDINATION OF BENEFITS
Updates attestations to reflect 2007 COB guidance.		Updates attestations to reflect guidance issued during 2006 for the 2007 contract year.	3.10A8-14		3.10A8-14			3.9A8-14
TRUE OUT-OF-POCKET COSTS (TrOOP)
Updates attestations to reflect 2007 COB guidance.		Updates attestations to reflect guidance issued during 2006 for the 2007 contract year.	3.11A3, 7-14		3.11A3, 7-14			3.10A3, 7-14
MEDICARE SECONDARY PAYER
Adds new attestations to reflect 2007 COB guidance.		Separates attestations that were included in the COB section that reflects guidance issued during 2006 for the 2007 contract year.	3.12		3.12			3.11
MARKETING/BENEFICIARY COMMUNICATION
Adds attestation related to cobranding.		Reflects guidance that was issued in the 2007 call letter.	3.13A8		3.13A8			3.12A8
Adds attestations related to marketing materials.		Reflects timeframes when beneficiaries are able to receive certain marketing materials from applicants.	3.13A9-11		3.13A9-11			3.12A9-11
PROVIDER COMMUNICATIONS
Added new attestations related to applicant websites and call centers dedicated to providers.		Reflects guidance that was issued in the 2007 call letter and subsequent CMS guidance.	3.14A2-3		3.14A2-3			3.13A2-3
COMPLIANCE PLAN
Deletes the requirement to provide specific explanations on how applicant’s compliance plan meets certain criteria and replaces these with the request to submit as an attachment of the applicant’s compliance table.		Applicant attests to meeting these criteria via the attestations and submits the compliance plan as an attachment.	3.15B-I		3.15B-I			3.14B-I
REPORTING REQUIREMENTS
Updates attestations related to rebate data and utilization management data reporting		Reflects guidance that was issued in the 2007 call letter and subsequent CMS guidance.	3.16A17-19		3.16A13-15			3.15A16-18
UPGRADES OF HEALTH INFORMATION TECHNOLOGY
Adds new attestations related to Applicant’s updated health information technology.		Attestation ensures applicant’s health information technology upgrades take into account interoperability standards recognized by HHS.	3.18		3.18			3.17
HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996
Adds new attestations related to payment and remittance notices, data security and protection of personal identifiable information.	Reflects guidance that was issued by CMS during the 2006 calendar year related to the acceptance of the HIPAA 835 claims form and guidance that was released related to inappropriate disclosures of beneficiary information. In addition, adds attestation related to off-shore activity that mirrors language included in FAR contracting.			3.19		3.19		3.18
CLAIMS PROCESSING
Adds a new attestation related to implementing new messaging approved by NCPDP workgroup related to adjudicating Part D claims.	Reflects guidance that was issued during the 2006 calendar year that requires Part D sponsors to adopt certain messaging to more effectively adjudicate Part D claims.			3.23A12		3.23A12		3.22A14
CERTIFICATION
Adds reference to the 2008 Call Letter.	Adds a reference that applicants agree they will abide by the forthcoming 2008 Call Letter.			4.0		4.0		4.0
APPENDICES
Clarifies language related to term of contract with subcontractor.	Clarifies that the term of the subcontract is for at least one-year and not the first year of the program.			Appendix VII		Appendix VI	Appendix V
Adds provision to crosswalk for Home Infusion Pharmacy Contracts.	Adds provision related to ensuring ancillary supplies and professional services are in place per guidance that was part of the 2007 Call Letter.			Appendix X		Appendix IX	Appendix VIII

*NOTE: Part D Service Area Expansion Application was amended to incorporate the Pharmacy Access Submission into the base solicitation.

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